Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 29
- 主要终点
- Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.
研究概览
简要总结
The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).
These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.
详细描述
Epidemiological evidence indicates that smoking during pregnancy increases the risk of many pregnancy related complications and is associated with many adverse postnatal problems. Around 15% of women still smoke throughout their pregnancy; younger women and those from more deprived backgrounds are much more likely to smoke. Behavioural support, available through NHS Stop Smoking Services, is effective but only accessed by a minority of smokers with most trying to quit alone. For this large group, self-help interventions may be an effective alternative.
MiQuit is a 12 week tailored, self-help, text-message intervention developed for pregnant smokers. A pilot study found this was feasible and acceptable for recipients, thus if MiQuit could have such an impact in routine NHS care, its low cost would make it highly cost-effective.
Before MiQuit could be used in routine care, a definitive randomised controlled trial (RCT) would be needed but currently there is insufficient information to justify conducting this.
This pilot trial will investigate whether it is possible to evaluate MiQuit in a multi-centre RCT located within the NHS, using research network resources. This study will recruit 400 pregnant smokers who will be randomly allocated to either MiQuit or control, and will provide estimates for the parameters required for determining the necessary resources for a definitive trial. These include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of trial participants in later pregnancy and ascertainment rates obtained; and the likely effect of MiQuit when women are offered this in NHS settings.
Secondary objectives include; To estimate and model the likely effectiveness and cost effectiveness of MiQuit compared with usual care including a generic smoking cessation information leaflet; To document participants' use of MiQuit interactive features and of NHS cessation support; To assess the effect of MiQuit on social cognitive determinants of quitting smoking and; To explore participant views and experiences of using MiQuit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant and less than 25 weeks gestation
- •Smoking at least 5 cigarettes per day pre-pregnancy
- •Smoking at least 1 cigarette on a typical day during pregnancy
- •Aged 16 or over
- •Agrees to accept information to assist cessation
- •Has own or has primary use of a mobile phone
- •Familiar with sending and receiving text messages
- •Able to understand written English (text messages are in English only) and consent issues explained in English.
- •Able to give informed consent
排除标准
- •Already enrolled in another text service to assist smoking cessation
研究组 & 干预措施
MiQuit
12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care
干预措施: MiQuit (Behavioral)
Control
Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
结局指标
主要结局
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.
时间窗: 36 weeks gestation
The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.
次要结局
- 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.(36 weeks gestation)
- Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.(36 weeks gestation)
- Reported Use of NHS and Other (Non-trial) Cessation Support(36 weeks gestation)
- Number of Requests to Stop Text Support(36 weeks gestation)
- 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.(36 weeks gestation)
- 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.(4 weeks post-randomisation)
- 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy.(36 weeks gestation)
- 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.(36 weeks gestation)
- Number of 24 Hour Quit Attempts(36 weeks gestation)